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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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N/A - 00816576024063

Campy CVA Agar, 15x100mm Plate, 18ml. Hardy Diagnostics Campy CVA Agar Plates are recommended for the selective isolation of Campylobacter species from fecal specimens.
HARDY DIAGNOSTICS
A40
In Commercial Distribution

  • 00816576024056 ()
  • 00816576024063 ()
A40

  • Differential/selective agar culture medium IVD

N/A - 00816576024049

GBS Detect, 15x100 monoplate, 10pks of 10 For the isolation and differentiation by enhanced hemolysis of gamma hemolytic Group B Streptococcus
HARDY DIAGNOSTICS
A300BX
In Commercial Distribution

  • 00816576024025 ()
  • 00816576024049 ()
A300BX

  • Differential/selective agar culture medium IVD

N/A - 00816576023899

StrePlate™, 15x100mm Monoplate, 22ml. Hardy Diagnostics' Bacti-Lab StrePlate™ is on enriched media for the selective isolation of all Streptococcus spp., including beta-hemolytic group A (Streptococcus pyogenes), group B (Streptococcus agalactiae), groups C, D, F and G; and Streptococcus pneumoniae.
HARDY DIAGNOSTICS
A150
In Commercial Distribution

  • 00816576023882 ()
  • 00816576023899 ()
A150

  • Differential/selective agar culture medium IVD

N/A - 00816576023851

Campy FDA Agar, 15x100, 10/pk (Campylobacter FDA Agar with amphotericin, novobiocin, polymyxin, trimethoprim, and vancomycin). For the isolation and cultivation of Campylobacter spp.
HARDY DIAGNOSTICS
A139
In Commercial Distribution

  • 00816576023844 ()
  • 00816576023851 ()
A139

  • Differential/selective agar culture medium IVD

N/A - 00816576023837

Campylobacter Blood Agar, 15x100mm plate, 18ml. Hardy Diagnostics Campylobacter Blood Agar is recommended for the primary isolation and cultivation of Campylobacter jejuni from human fecal specimens.
HARDY DIAGNOSTICS
A137
In Commercial Distribution

  • 00816576023820 ()
  • 00816576023837 ()
A137

  • Differential/selective agar culture medium IVD

N/A - 00816576023813

Arcanobacterium Selective Agar, 15x100mm Plate, 17ml. Hardy Diagnostics Arcanobacterium Selective Agar is recommended for use as a selective medium for the isolation of Arcanobacterium haemolyticum, especially from respiratory specimens.
HARDY DIAGNOSTICS
A134
Not in Commercial Distribution

  • 00816576023806 ()
  • 00816576023813 ()
A134

  • Differential/selective agar culture medium IVD

N/A - 00816576023790

Campy Cefex Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics Campy Cefex Agar, Modified plates are recommended for the selective isolation of cephalothin-resistant Campylobacter species such as C. jejuni , C. coli , and C. lari from human, animal, or food samples.
HARDY DIAGNOSTICS
A122
In Commercial Distribution

  • 00816576023783 ()
  • 00816576023790 ()
A122

  • Differential/selective agar culture medium IVD

N/A - 00816576023776

Blood Agar with Ampicillin, 15x100mm Plate, 17ml. Hardy Diagnostics Blood Agar with Ampicillin is recommended for the cultivation and selective isolation of Aeromonas spp.
HARDY DIAGNOSTICS
A12
In Commercial Distribution

  • 00816576023769 ()
  • 00816576023776 ()
A12

  • Differential/selective agar culture medium IVD

N/A - 00816576023523

DTM Agar (Dermatophyte Test Medium) A selective and differential medium for the detection and presumptive identification of dermatophytes from clinical and veterinary specimens
HARDY DIAGNOSTICS
1020
Not in Commercial Distribution

  • 00816576023516 ()
  • 00816576023523 ()
1020

  • Differential/selective agar culture medium IVD

HardyCHROM - 00816576023370

HardyCHROM Candida + auris Recommended for the selective isolation and differential identification of yeast. The medium allows for the differentiation of C. albicans , C. tropicalis, C. krusei, and C. auris based on colony morphology, color, and positive UV fluorescence. This medium facilitates the detection of mixed yeast cultures.
HARDY DIAGNOSTICS
G343
In Commercial Distribution

  • 00816576023103 ()
  • 00816576023370 ()
G343

  • Differential/selective agar culture medium IVD
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